Home NDC 70748-389 Prucalopride
Product NDC 70748-389
11-digit product format 707480389
Labeler code 70748
Product ID 70748-389_b9640796-d193-4aff-b1d3-9399b0607d5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prucalopride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA218847
Marketing category ANDA
Marketing start 2025-06-25
Substance PRUCALOPRIDE SUCCINATE
Active strength 1 mg/1
Pharmacologic classes Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218847-001 PRUCALOPRIDE SUCCINATE PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2025-06-24 A218847-002 PRUCALOPRIDE SUCCINATE PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2025-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A218847-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2025-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218847-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2025-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218847-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2025-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218847-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2025-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218847-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2025-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218847-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2025-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218847-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2025-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218847-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2025-06-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218847-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2025-06-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218847-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2025-06-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Prucalopride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRUCALOPRIDE SUCCINATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4V2G75E1CK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2107345 Internal RxNorm lookup 2107353 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70748-389-01 Prucalopride 30 in 1 BOTTLE TABLET, FILM COATED 30 7
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70748-389-01 70748038901 30 TABLET, FILM COATED in 1 BOTTLE (70748-389-01) 2025-06-25 No No Current